CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY
Randomized Double-Blind Comparison of Sirolimus-Eluting Stent Versus Bare-Metal Stent Implantation in Diseased Saphenous Vein Grafts
Six-Month Angiographic, Intravascular Ultrasound, and Clinical Follow-Up of the RRISC Trial
Paul Vermeersch, MD*,1,*,
Pierfrancesco Agostoni, MD*,1,
Stefan Verheye, MD, PhD*,
Paul Van den Heuvel, MD*,
Carl Convens, MD*,
Nico Bruining, PhD ,
Frank Van den Branden, MD* and
Glenn Van Langenhove, MD, PhD*
* Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Antwerp, Belgium
Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands.
Manuscript received May 3, 2006;
revised manuscript received July 17, 2006,
accepted July 18, 2006.
* Reprint requests and correspondence: Dr. Paul Vermeersch, Antwerp Cardiovascular Institute Middelheim, AZ Middelheim, Lindendreef 1, 2020 Antwerp, Belgium. (Email: paul.vermeersch{at}zna.be).
OBJECTIVES: We sought to compare, in a randomized fashion, sirolimus-eluting stents (SES) versus bare-metal stents (BMS) in saphenous vein grafts (SVGs).
BACKGROUND: Sirolimus-eluting stents reduce restenosis and repeated revascularization in native coronary arteries compared with BMS. However, randomized data in SVG are absent.
METHODS: Patients with SVG lesions were randomized to SES or BMS. All were scheduled to undergo 6-month coronary angiography. The primary end point was 6-month angiographic in-stent late lumen loss. Secondary end points included binary angiographic restenosis, neointimal volume by intravascular ultrasound and major adverse clinical events (death, myocardial infarction, target lesion, and vessel revascularization).
RESULTS: A total of 75 patients with 96 lesions localized in 80 diseased SVGs were included: 38 patients received 60 SES for 47 lesions, whereas 37 patients received 54 BMS for 49 lesions. In-stent late loss was significantly reduced in SES (0.38 ± 0.51 mm vs. 0.79 ± 0.66 mm in BMS, p = 0.001). Binary in-stent and in-segment restenosis were reduced, 11.3% versus 30.6% (relative risk [RR] 0.37; 95% confidence interval [CI] 0.15 to 0.97, p = 0.024) and 13.6% versus 32.6% (RR 0.42; 95% CI 0.18 to 0.97, p = 0.031), respectively. Median neointimal volume was 1 mm3 (interquartile range 0 to 13) in SES versus 24 (interquartile range 8 to 34) in BMS (p < 0.001). Target lesion and vessel revascularization rates were significantly reduced, 5.3% versus 21.6% (RR 0.24; 95% CI 0.05 to 1.0, p = 0.047) and 5.3% versus 27% (RR 0.19; 95% CI 0.05 to 0.83, p = 0.012), respectively. Death and myocardial infarction rates were not different.
CONCLUSIONS: Sirolimus-eluting stents significantly reduce late loss in SVG as opposed to BMS. This is associated with a reduction in restenosis rate and repeated target lesion and vessel revascularization procedures. (The RRISC Study; http://clinicaltrials.gov/ct/show; NCT00263263
[ClinicalTrials.gov]
).
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Abbreviations and Acronyms
| | BMS = bare-metal stent | | CI = confidence interval | | IVUS = intravascular ultrasound | | MACE = major adverse cardiac event | | MI = myocardial infarction | | MLD = minimal luminal diameter | | PCI = percutaneous coronary intervention | | RR = relative risk | | RVD = reference vessel diameter | | SES = sirolimus-eluting stent | | SVG = saphenous vein graft | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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